Professional Documents
Culture Documents
Designation: E 2183 – 02
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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Clinical Document Architecture: Level 1 the markup. A parser that reads a DTD and checks and reports
2.4 IETF Specifications, (http://www.ietf.org) on markup errors is a validating XML parser. A parser can be
RFC 2396: Uniform Resource Indentifiers (URI), http:// built into an XML editor to prevent incorrect tagging and to
ietf.org/rfc/rfc2396 check whether a document contains all the required elements.
3. Terminology 3.1.9 schema, n—defines the elements that can appear
within the document and the attributes that can be associated
3.1 Definitions:
with an element. It also defines the structure of the document:
3.1.1 clinical document, n—defined in terms of the native
which elements are child elements of others, the sequence in
XML and hypertext architecture. The Document Type Defini-
which the child elements can appear, and the number of child
tion (DTD) is the base method of defining the structure of a
elements. It defines whether an element is empty or can include
clinical document. XML schema languages such as the W3C
XML Schema Language and the OASIS RELAXNG Schema text. The schema can also define default values for attributes.
language provide alternative methods of defining clinical Schema is a W3C term for the next generation of DTDs.
document structures. 3.1.10 stylesheet, n—the XSL Transformations (XSLT) de-
3.1.2 clinical document architecture (CDA), n—the HL7 scribes a vocabulary recognized by an XSLT processor to
CDA is a document markup standard for the structure and transform information from an organization in the source file
semantics of exchanged clinical documents. A clinical docu- into a different organization suitable for continued downstream
ment is a documentation of observations and other services processing. The Extensible Stylesheet Language (XSL) de-
with the following characteristics: Persistence, Stewardship, scribes a vocabulary recognized by a rendering agent to reify
Potential for Authentication, Wholeness, and Human Readabil- abstract expressions of format into a particular medium of
ity. A clinical document is a defined and complete information presentation.
object that can exist outside of a message, and can include text, 3.1.11 URI, n—identifies a Web resource according to IETF
sounds, and other multimedia content. RFC 2396. Used in practice to form links between, to name,
3.1.3 document type definition (DTD), n—formal definition and to locate web documents. Also used to name XML
of the elements, structures, and rules for enabling platform namespaces.
independent data access via XML or for marking up a given
3.1.12 valid XML document, n—well-formed with internal
type of SGML document.
or DOCTYPE reference to element definition of tags within the
3.1.4 extensible markup language (XML), n—a standard
document.
from the World Wide Web Consortium (W3C) that provides for
tagging of information content within documents, offering a 3.1.13 W3C (World Wide Web Consortium), n—develops
means for representation of content in a format which is both interoperable technologies (specifications, guidelines, soft-
human and machine readable. Through the use of customizable ware, and tools) to lead the Web to its full potential as a forum
style sheets and schemas, information can be represented in a for information, commerce, communication, and collective
uniform way, allowing for interchange of both content (data) understanding.
and format (metadata). 3.1.14 well-formed XML document, n—an XML document
3.1.5 Health Level 7 (HL7), n—a standards organization that conforms to the syntax as specified by the W3C XML 1.0
traditionally focused on message-oriented standards for health- recommendation.
care. HL7 messages are the dominant standard for peer-to-peer 3.1.15 XHTML, n—HTML documents that are well formed
exchange of clinical, text-based information. HL7 has recently and can be processed by an XML parser.
introduced a document-oriented standard, the Clinical Docu-
3.1.16 XLINK, n—the W3C XML Linking Language de-
ment Architecture.
fines a method for specifying links between documents and
3.1.6 hypertext markup language (HTML), n—the language
parts of documents using URIs. Links may be simple, repre-
used in creating a web page. Its origin is an implementation of
senting a 1:1 mapping or extended, representing anN:N map-
SGML DTD, but whose most recent update is defined in XML
(XHTML). It provides tags regarding the way a document ping.
should be displayed in the text of an HTML document, which 3.1.17 XPointer, n—the XML Pointer Language, defines
act as commands that a browser interprets when downloading how individual parts of a document are addressed. XLinks
an HTML file. point to a URI (in practice, a URL) that specifies a particular
3.1.7 namespaces, n—provide a simple method for qualify- resource. The URL may include an XPointer part that more
ing element and attribute names used in XML documents. This specifically identifies the desired part or section of the targeted
is accomplished by associating a particular tag set by associ- resource or document. XPointer, the XML Pointer Language,
ating a prefix with a URI reference. XML Namespaces provide defines an addressing scheme for individual parts of an XML
a mechanism for authoring compound documents (documents document. XLinks point to a URI (in practice, a URL) that
consisting of elements and attributes from multiple DTDs or specifies a particular resource. The URI may include an
schemas) in such a way that will provide global identification XPointer part that more specifically identifies the desired part
without collisions of names that are the same but are used or element of the targeted resource or document. XPointers use
differently. the same XPath syntax familiar to XSL transformations to
3.1.8 parser, n—a specialized software program that recog- identify the parts of the document they point to, along with a
nizes markup in a document and differentiates the content from few additional pieces.
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4. Summary of Guide tecture. Using the results of the workshop, this guide, Standard
4.1 Philosophy of E31 XML DTDs—The philosophy of Practice for XML DTDs for Health Care: GEM: A Document
ASTM Subcommittee E31.28 was initially based on the Model for Clinical Practice Guidelines, Specification E 2182 ,
premise that a set of document types for healthcare does not and other DTDs would be developed.
exist. It is not known if health care documents have common 4.4 The philosophy in DTD design includes the following:
and identifiable structures. It is generally accepted that some 4.4.1 Simplicity of XML document structure,
regularity exists and that this regularity could be used to create 4.4.2 Agreement on high level structures in clinical docu-
standard high level structures. These standard structures could ments,
then be easily manifested in XML DTDs. Regularity in 4.4.3 Ability for International Representations in the XML,
document structure is identified by document analysis, review 4.4.4 Make use of existing standards where possible, and
of health care informatics standards and research and comple- 4.4.5 Maintain readability.
mentary technology standards. 4.5 Architecture and Design of DTDs—The ASTM DTDs
4.2 Two workshops were held to design and develop the have been designed to have a common architecture. This
DTDs. The results of the workshops identified the following: architecture defines a document to consist of a document
4.2.1 The sections or categories that exist in clinical docu- header and a document body. The header may be specific to a
ments, particular document type. For instance, the Standard Practice
4.2.2 The order of the sections, if the sequence is important, for XML DTDs for Health Care: GEM: A Document Model
and includes a header that is specific to guidelines in Health Care.
4.2.3 The number of times the different sections appear in 4.6 Format and Common Features—Formatting informa-
clinical document types. tion and common features frequently found in these documents
4.3 The supporting materials and knowledge of clinical include:
documentation was used to determine the sections, the order of 4.6.1 Basic text (including headings, paragraphs, and lists),
the sections and the number of times the sections appeared in 4.6.2 Hyperlinks and links to related documents,
document. This included a review of transcribed reports for 4.6.3 Forms,
common areas, sections and sub-sections, government forms 4.6.4 Tables,
for categories for data entry, and demographic information 4.6.5 Images, and
contained within the header of the Clinical Document Archi- 4.6.6 Meta information.
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4.7 The design provides for tags that represent common multiple software modules. For instance, the following XML
items such as paragraphs, images and tables. This is provided tags listed below are both valid <Citation> elements. The
by inclusion of the XHTML Basic DTD and the tags, which it Citation elements are defined differently in the DTDs. One
contains. XHTML Basic is designed as a common base that representation makes use of elements and the other makes use
may be extended. The motivation for using XHTML Basic is to of attributes.
incorporate an XHTML document type that can be shared <Citation
across communities, is rich enough to be used for simple Author=9Tunstall-Pedoe, H.9
content authoring, and has the ability to be extended as future Title=9What’s in a name?9
Source=9W3C, 1999 Nov; 317:1-49/>
versions of this guide are developed.
4.8 By allowing the inclusion of XHTML tags, format <Citation>
information may be included within the documents in a <Author>
Tunstall-Pedoe, H.
standard way. The author of the DTD determines which parts </Author>
of the XHTML standard are to be used. A subset of XHTML <Title>
has been developed for use in E 2183 DTDs and is included in What’s in a name?
</Title>
this guide. Some modules of XHTML were not included in the <Source>
ASTM XHTML. These modules include forms and web W3C, 1999 Nov;
specific tags (such as the <HTML> tag itself). Additionally, 317:1-4
</Source>
some attributes of XHTML, which specify the language of the </Citation>
document, are used to indicate sections that are in different
languages (such French or German). Below is an example 4.10 Both versions are defined in a DTD and are defined
operative report, which makes use of the E31.25 architecture differently. The January 1999 W3C recommendation on
and XHTML within the sections. namespaces solves the problem of different content models.
4.9 XML Namespaces—XML Namespaces is a W3C rec- Namespaces allow for a prefix to be added to the element. This
ommendation that allows for a single XML document to prefix allows for tag names to be unique. Conflicts are avoided
contain elements and attributes that are defined for and used by for elements and attributes with the same name.
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5.2.4 Body Sections—The DTDs will create section level DTD defined by using this guide and using a validating XML
tags. Parser according to the W3C XML 1.0 recommendation,
5.3 XHTML Basic—XHTML Basic consists of the follow- http://www.w3.org/TR/2000/REC-xml-20001006. A conform-
ing XHTML modules: ant document must validate without errors according to XML
5.3.1 Structure Module—body, head, html, title. 1.0. When developing software to create and edit clinical
5.3.2 Text Module—abbr, acronym, address, blockquote, br, documents, it is desirable to customize DTDs according to the
cite, code, dfn, div, em, h1, h2, h3, h4, h5, h6, kbd, p, pre, q, specific needs of the editing or other software. This is advis-
samp, span, strong, var. able. It is not required nor even encouraged that the standard
5.3.3 Hypertext Module—a. DTDs be used unmodified during the editing process. It is the
5.3.4 List Module—dl, dt, dd, ol, ul, li. final document output or the editor, or other transformation
5.3.5 Basic Forms Module—form, input, label, select, op- software, which must conform to the standard DTDs.
tion, textarea. 6.2 Conformant XML DTDs and Documents—A conform-
5.3.6 Basic Tables Module—caption, table, td, th, tr. ant document must also conform to constraints expressed
5.3.7 Image Module—img. within the prose of this guide; however, this guide does not
5.3.8 Object Module—object, param. express a formal means of testing conformance to such
5.3.9 Metainformation Module—meta. additional constraints such as adherence to the architecture.
5.3.10 Link Module—link. The E 2183 DTDs must conform to the architecture, naming
5.3.11 Base Module—base. conventions, inclusion of XHTML, and allow for namespace
5.4 A modularized XHTML Basic DTD was developed for usage as defined in this guide.
use with the ASTM DTDs. This modularized DTD does not
contain the following modules: 7. Significance and Use
5.4.1 Structure Module—body, head, html, title. 7.1 The intended use of this guide is as an outline for the
5.4.2 Basic Forms Module—form, input, label, select, op- development of E 2183 DTDs.
tion, textarea.
5.4.3 Metainformation Module—meta. 8. Procedure
5.4.4 Base Module—base. 8.1 This guide is to be used as the template for E 2183 DTD
5.5 Namespaces—The namespaces recommendation was design, architecture, and development. E 2183 architecture
specified after the XML Version 1.0 Recommendation and DTDs have the following DTDs:
there are some issues merging DTDs and namespaces. DTDs 8.1.1 The top level DTD that is named appropriately and
and validity are concepts defined in XML 1.0. The XML according to its document type. For instance, an operative
Namespace recommendation came after the XML 1.0 recom- report DTD will have a top-level DTD named “operative.re-
mendation and is layered on top of XML 1.0. The XML port.dtd.”
Namespaces recommendation does not redefine validity. The 8.1.2 The E 2182/E 2183 base DTD includes the ASTM
implication of this is that validity is the same for a document modularization of XHTML. The inclusion of the ASTM
that uses XML Namespaces and one that doesn’t. Because of XHTML DTD allows the top level DTD to include XHTML
this, XML documents that are expect to be valid are not and elements within the header and body elements. For instance, a
documents that are expected to be invalid are valid. The section element such as <guideline.title> may make use of the
guidelines for writing documents that are both valid and XHTML heading elements such as <h1> and <h2> or other
conform to the XML Namespaces recommendation are: format elements such as bold <b> and italic <i>.
5.5.1 Declare all xmlns attributes in the DTD, 8.1.3 When appropriate, the clinical header defined as a
5.5.2 Use the same qualified names in the DTD and the non-mandatory part of this guide may be used.
body of the document, 8.1.4 The sections of the body of the E 2183 document are
5.5.3 Use one prefix per XML Namespace, then assigned as appropriate for the document type.
5.5.4 Do not use the same prefix for more than one XML 8.1.5 For example, the E 2182 Clinical XML DTDs for
Namespace, and Healthcare have been designed according to E 2183.
5.5.5 Use at most one default XML Namespace.
5.6 Header Requirements—The ASTM Clinical Header 9. Precision and Bias
DTD was designed to be compatible with the HL7 CDA 9.1 Precision to the DTD architecture is determined by
Header in order to facilitate conversion of an ASTM Clinical XML validating parsers and conformance to this guide.
Header to the HL7 CDA Header using an XSLT transform. The 9.2 The DTDs have been tested against several validators.
ASTM Subcommittee E31.25 develops headers specific to the An online XML document validator produced by the Brown
needs of the ASTM documents. Different document types will University Scholarly Technology Group (STG) is available at
require different document specific information. A common the URL: http://www.stg.brown.edu/service/xmlvalid/.
clinical header is included in this guide but its use is not 9.3 Other online validators include:
required. 9.3.1 Language Technology Group at University of Edin-
burgh: http://www.ltg.ed.ac.uk/~richard/xml-check.html.
6. Scope 9.3.2 The W3C web validator: http://validator.w3.org.
6.1 Valid XML Documents with DTDs—A document is 9.4 In order to facilitate such online testing, the DTDs and
tested for conformance to this guide by referencing an ASTM sample documents have been placed in the directory http://
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www.openhealth.org/ASTM/; for example, operative.repor- 9.6 Furthermore, Microsoft’s IE5 frequently hangs when
t.example.xml. This directory will contain links software attempting to parse XML files with external DTD subsets. The
demonstrating use of the E 2183 DTDs and Schemata as they solution is to remove the <!DOCTYPE> declaration when
are developed. browsing XML files using IE5 and use the MSXML as a
9.5 There is a good deal of inconsistency in parsing and non-validating parser. For this reason compliant documents
validating against the W3C XHTML Basic 1.0 recommenda- must not depend on DTD attribute defaulting and must
tion. In particular XML Authority 2.0 reports many warnings explicitly include attribute values for #FIXED attributes.
as errors (for example, undefined elements). Many warnings
are generated from the XHTML Basic DTDs, for example, 10. Keywords
regarding DTD defaulted namespace declarations. These are
correctly warnings not errors and do not affect document 10.1 architecture; DTD; health care; healthcare;
validity. namespaces; XHTML; XLink; XML; XPointer
ANNEX
(Mandatory Information)
This DTD is derived from the W3C XHTML Basic Driver DTD:
-->
9http://www.w3.org/1999/xhtml9
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<!-- For example, if you are using XHTML Basic 1.0 directly, use
the FPI in the DOCTYPE declaration, with the xmlns attribute
on the document element to identify the default namespace:
<?xml version=91.09?>
<!DOCTYPE html PUBLIC 9-//W3C//DTD XHTML Basic 1.0//
EN9
9http://www.w3.org/TR/xhtml-basic/xhtml-basic10.dtd9 >
<html xmlns=9http://www.w3.org/1999/xhtml9
xml:lang=9en9>
...
</html>
-->
<?IS10744:arch xhtml
<!ENTITY % xhtml-basic10-module.dtd
PUBLIC 9-//W3C//DTD XHTML Basic 1.0//EN9
9http://www.w3.org/TR/xhtml-basic/xhtml-basic10.dtd9>
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%xhtml-basic10-module.dtd;
<!--
PUBLIC 9-//ASTM//DTD E 2182 Base 1.0//EN9
SYSTEM 9http://www.openhealth.org/ASTM/ASTM.E 2182.dtd9
-->
%xlink.namespace.attrib;
9>
<!--
The content of ASTM Healthcare documents may include XLinks
PUBLIC //ASTM//ENTITIES Xlink 1.0//EN9
SYSTEM 9http://www.openhealth.org/ASTM/astm-xlink.mod9
-->
<!ENTITY % xlink.namespace.uri 9’http://www.w3.org/1999/xlink’9>
<![ %no.namespace.support; [
<!ENTITY % xlink.namespace.attrib 99>
]]>
<![ %XLINK.namespace.prefixed; [
<!ENTITY % XLINK.pfx 9xlink:9>
<!ENTITY % XLINK.sfx 9:xlink9>
<!ENTITY % xlink.type.qname 9xlink:type9>
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<!ENTITY % xlink.arcrole.qname 9xlink:arcrole9>
<!ENTITY % xlink.href.qname 9xlink:href9>
<!ENTITY % xlink.attrib 9
xlink:type (simple|extended|locator|arc|resource|title) #IMPLIED
xlink:arcrole CDATA #IMPLIED
xlink:href CDATA #IMPLIED
xlink:role CDATA #IMPLIED
xlink:title CDATA #IMPLIED
9>
<!ENTITY % xlink.simple.attrib 9
xlink:type (simple|extended) 9simple9
xlink:arcrole CDATA #IMPLIED
xlink:href CDATA #IMPLIED
xlink:role CDATA #IMPLIED
xlink:title CDATA #IMPLIED
’>
<!ENTITY % xlink.extended.attrib ’
xlink:from CDATA #IMPLIED
xlink:to CDATA #IMPLIED
xlink:label CDATA #IMPLIED
’>
]]>
<!ENTITY % xlink.attrib 9
type (simple|extended) #IMPLIED
arcrole CDATA #IMPLIED
href CDATA #IMPLIED
9>
<!ENTITY % xlink.simple.attrib ’
type (simple|extended) 9simple9
arcrole CDATA #IMPLIED
href CDATA #IMPLIED
’>
APPENDIX
(Nonmandatory Information)
<!--
PUBLIC 9-//ASTM//DTD Clinical Header 1.0//EN9
SYSTEM 9http://www.openhealth.org/ASTM/clinical.header.dtd
<!ENTITY % astm-xlink.mod
PUBLIC 9-//ASTM//ENTITIES XLink 1.0//EN9
9astm-xlink.mod9>
%astm-xlink.mod;
<!ENTITY % ch.namespace.uri 9’http://www.openhealth.org/ASTM/
clinical.header’9>
<!ENTITY % ch 9ch9>
<![ %CH.prefixed; [
<!ENTITY % ch.prefix 9%ch;:9>
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<!ENTITY % ch.namespace.attrib 9
xmlns:%ch; CDATA #FIXED ’http://www.openhealth.org/ASTM/
clinical.header’
9>
]]>
<!ENTITY % ch.attrib 9
ID ID #IMPLIED
confidentiality IDREF #IMPLIED
note CDATA #IMPLIED
xml:lang NMTOKEN #IMPLIED
9>
<!--<!ENTITY % ch.xmlns.attrib.name 9xmlns:%ch;9>-->
<!ENTITY % ch-qname.mod
PUBLIC 9–//ASTM//ENTITIES Clinical Header QName
Module 1.0//EN9
9clinical.header-qname-1.mod9>
%ch-qname.mod;
<!ENTITY % ch.person.type
9%person.name.qname;,(%id.qname;)*,(%addr.qname;)*9>
<!ENTITY % ch.organization.type
9(%organization.name.qname;)?,(%id.qname;)*,(%addr.qname;)*9>
<!ENTITY % ch.actor.type
9%ch.person.type;,(%type.code.qname;)?,(%date.time.qname;)?9>
<!ENTITY % ch.authenticator.type
9%ch.actor.type;,(%signature.qname;)?9>
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<!ENTITY % service.actor.model 9(
(%person.name.qname;|%organization.name.qname;),
(%id.qname;)*,
(%addr.qname;)*,
(%type.code.qname;)?,
(%function.qname;)?,
(%date.time.qname;)?
)9>
<!ENTITY % provider.model
9(%ch.actor.type;,(%function.qname;)?)9>
<!ENTITY % service.target.model 9(
%ch.actor.type;,
(%birth.date.qname;)?,
(%gender.qname;)?
)9>
<!ENTITY % events.model 9(%event.qname;)*9>
<!ENTITY % event.model
9(%event.name.qname;,%date.time.qname;,(%staff.qname;)?,(%comments.qname;)?)9
>
<!ENTITY % person.name.model 9(
%family.qname;|
%given.qname;|
%middle.qname;|
%prefix.qname;|
%suffix.qname;|
%delimiter.qname;
)*
9>
<!ENTITY % addr.model 9(
%country.qname;|
%city.qname;|
%state.qname;|
%street.qname;|
%zip.qname;|
%house.number.qname;|
%direction.qname;|
%post.office.box.qname;|
%telephone.qname;|
%uri.qname;|
%delimiter.qname;
)*9
>
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<!ATTLIST %patient.qname; %ch.attrib; %xlink.attrib;>
<!ELEMENT %events.qname; %events.model;>
<!ATTLIST %events.qname; %ch.attrib;>
<!ELEMENT %codes.qname; (%coded.value.qname;)*>
<!ATTLIST %codes.qname; %ch.attrib;>
<!ELEMENT %related.document.qname; ANY>
<!ATTLIST %related.document.qname; %xlink.simple.attrib;>
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<!ELEMENT %address.locator.qname; %text.model;>
<!ATTLIST %address.locator.qname; %ch.attrib;
type CDATA #IMPLIED>
<!ELEMENT %post.office.box.qname; %text.model;>
<!ATTLIST %post.office.box.qname; %ch.attrib;
type CDATA #IMPLIED>
<!--
allows
<uri type=9email9>jonathan@openhealth.org</uri>
<uri type=9homepage9>http://www.openhealth.org</uri>
alternatively
<uri type=9home9>mailto:jonathan@openhealth.org</uri>
<uri type=9work9>mailto:jborden@lifespan.org</uri>
-->
<!ELEMENT %uri.qname; %text.model;>
<!ATTLIST %uri.qname; %ch.attrib;
type CDATA #IMPLIED>
<!ELEMENT %telephone.qname; %text.model;>
<!ATTLIST %telephone.qname; %ch.attrib;
type CDATA #IMPLIED>
<!ELEMENT %originating.organization.qname;
(%ch.organization.type;)>
<!ATTLIST %originating.organization.qname; %ch.attrib;>
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